Evaluation of Medical Devices for Product Development and Health Technology Assessment

Our academic partner, University of York, is running a course which provides a comprehensive overview of key issues associated with the clinical and economic evaluation of medical devices and the creative alternative methods available to robustly evaluate them.

It is aimed at medical device developers, manufacturers, regulators, healthcare practitioners, analysts, consultants, and health technology assessors interested in optimising the evidence generation processes aimed at informing key decisions they are faced with throughout the full development and evaluation pathway of medical devices.

Those attending may be new to the field of health technology assessment of medical devices but wish to appreciate and appraise studies done by others and commission research to support value claims associated with medical devices part of submissions to regulatory and health technology assessment agencies.  Similarly, the course will be suitable for experienced analysts interested in having a deeper understanding of medical device evaluation.

Learning outcomes

To inform and promote understanding of key challenges associated with the evaluation of medical devices to estimate their expected value from early stages of development through to HTA (e.g. safety, clinical efficacy, effectiveness, and cost effectiveness). At the end of the course, participants will be able to:

  • describe key characteristics of medical devices that have direct impact on the type of analytical methods required to evaluate  proof of concept, safety, efficacy, effectiveness and cost-effectiveness of these products
  • design an efficient evidence generation strategy that will enable them to collect appropriate data (e.g. clinical, epidemiological, resource use, health related quality of life, preferences) to support value claims from early stages of development through to HTA
  • understand alternative methods available to demonstrate treatment effect in terms of improvements in efficiency and those required to demonstrate equivalent or differential clinical efficacy, effectiveness and cost-effectiveness
  • conceptualise the decision problem and identify appropriate evaluation methods to ascertain the expected value of medical devices from early stages of development through to HTA
  • engage critically with published evidence and determine its potential contribution to inform decisions regarding the mechanism of action, safety, efficacy, effectiveness and cost effectiveness of medical devices
  • define the type of analyses required to robustly evaluate medical devices and understand the need to characterise, explicitly and fully, the uncertainty associated with value estimates.